Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Jaw, Edentulous, Partially Clinical Trial

Official title:

Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487758
• Other study ID #: 15.0531
• Status: Completed
• Phase: N/A
• First received: June 19, 2015
• Last updated: December 6, 2016
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: December 2016
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring BoardUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Description:

Thirty patients will be treated using the principles of guided bone regeneration and ridge preservation. Fifteen test patients will receive the flapless technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. The positive control group of fifteen patients will receive the flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR. Approximately, four months post-surgery, a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.

2. Healthy male or female who is at least 18 years old.

3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.

2. Presence or history of osteonecrosis of jaws.

3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.

4. Patients who have been treated with oral bisphosphonates for more than three years.

5. Patients with an allergy to any material or medication used in the study.

6. Previous head and neck radiation therapy.

7. Chemotherapy in the previous 12 months.

8. Pregnant patients.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Jaw, Edentulous, Partially

Intervention

Procedure:
• Ridge Preservation
Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in post-extraction site to 4 month change in crestal osseous width	Changes in post-extraction to 4 month change in ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.	4 months	No
Secondary	Change in Soft tissue thickness	Soft tissue thickness measurements taken with a #40 endodontic reamer.	4 months	No
Secondary	Percent osseous tissue	A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space.	4 months	No